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FDA 510(k)

COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO

K-Number: K090991 · 2009-10-09

ApplicantE-Woo Technology
Decision Date2009-10-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO is the device name listed in this FDA 510(k) record. The listed applicant is E-Woo Technology. It received FDA 510(k) clearance on 2009-10-09 under 510(k) number K090991. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO?

COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is E-Woo Technology. The 510(k) number is K090991.

When did COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO receive FDA 510(k) clearance?

COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO received FDA 510(k) clearance on 2009-10-09, under 510(k) number K090991.

Who is the listed applicant for COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO?

The FDA 510(k) record lists E-Woo Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO?

The FDA product code for COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO is JAK.

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Other records listing E-Woo Technology as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K091090DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717K090526MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSORK090171COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3DK082410MASTER3DSK081847PICASSO MASTER, ECT AND MASTER 3DK070658DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM

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Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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